의료 디오드 레이저 시스템 (THEIA808)

Medical Diode Laser Systems (THEIA808) is the device name listed in this FDA 510(k) record. The listed applicant is Gigaalaser Company , Ltd.. It received FDA 510(k) clearance on 2025-04-01 under 510(k) number K250018. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.